Abuse of prescribed drugs such as benzodiazepines, amphetamines, amphetamine-like drugs, and opioid narcotics pose a major health risk and numerous enforcement problems in the United States and worldwide.
Benzodiazepines are anxiolytic (anxiety-relieving), hypnotic (sleep-inducing) and increase a patient's seizure threshold. Benzodiazepines are prescribed for medical conditions including anxiety, insomnia, alcohol withdrawal, seizures and as anesthetic agents given prior to and during surgery. The class of benzodiazepines contains many different medications. A partial list includes: midazolam (Versed), triazolam (Halcion), alprazolam (Xanax), lorazepam (Ativan), chlordiazepoxide (Librium), diazepam (Valium), bromazepam (Lexotan), flunitrazepam (Rohypnol, the “date-rape” drug), flurazepam (Dalmane), nitrazepam (Mogadon), oxazepam (Serenid), and temazepam (Restoril, Normison, Euhypnos). Benzodiazepines act on the central nervous system through interactions with gamma amino butyric acid (GABA) receptors. A physician, or para-professional, must hold a current and valid DEA certificate and be in good standing to prescribe a benzodiazepine. Benzodiazepines, while widely prescribed for a number of indications, are especially prone to substance abuse because they are rapidly acting anxiolytic agents.
The DEA recognizes the high propensity for abuse of benzodiazepines and has thus classified benzodiazepines as schedule IV medications. Benzodiazepine abusers often engage in “doctor-shopping,” i.e., obtaining overlapping benzodiazepine prescriptions from different physicians. Doctors' prescriptions are the primary source of illicit benzodiazepines (Ashton H, Drugs and Dependence. 2002; 197-212 (Harwood Academic Publishers)). Benzodiazepines are often mixed with alcohol and commonly form part of a polysubstance abuse pattern, which can include heroin, opioids, cocaine and amphetamines (see Ashton). When benzodiazepines are mixed with alcohol, the intoxicating effects are not merely additive, but synergistic, and pose significant additional safety risks to individuals operating motor vehicles, passengers in their vehicles and those who share the road with them.
Amphetamines are used to treat medical conditions including Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), narcolepsy, depression, and historically were used as appetite suppressants or weight loss medications. The family of compounds derived from amphetamine (Benzedrine) include dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), benzphetamine (Didrex) and a number of others.
Methylphenidate (Ritalin) is an amphetamine-like drug prescribed for the treatment of the same disorders as amphetamines, perhaps with a somewhat lower probability of producing addictions. Both methylphenidate and its analogues, as well as the amphetamines and their analogues, are frequently prescribed to children and unfortunately are often used and abused by older siblings and others. On many college campuses, university students have found that crushing and snorting methylphenidate and amphetamines can produce cocaine-like euphoria.
Long-term, high dosage use of amphetamines and amphetamine-like drugs can result in symptoms of anxiety, panic, hallucinations and paranoia. Because these agents are sympathomimetic, they also act to increase heart rate, blood pressure and, at times, insomnia. Amphetamines and amphetamine-like drugs are extremely psychologically addictive because they increase brain dopamine levels and specifically target the brain's reward center, i.e., the nucleus accumbens.
A publication, Monitoring the Future Survey (MTF), funded by the National Institute on Drug Abuse, National Institutes of Health, and Department of Health and Human Services assesses the extent of drug use among adolescents and young adults in the United States. The 2003 MTF data on annual use indicate that 2.6% of 8th-graders abused Ritalin, as did 4.1% of 10th-graders and 4.0% of 12th-graders.
Opioids are commonly prescribed for their effective analgesic properties. Some of the medications that fall within this class include morphine, codeine, oxycodone (OxyContin), propoxyphene (Darvon), hydrocodone (Vicodin), hydromorphone (Dilaudid), and meperidine (Demerol). In addition to their pain-relieving properties, some of these drugs—for example, codeine and diphenoxylate (Lomotil)—can be used to relieve coughs and diarrhea. Long-term use of opioids can lead to physical dependence and addiction.
The methods of the present invention can stop or prevent prescription drug abuse because a patient is denied access to a second, overlapping prescription and doctor-shopping is effectively thwarted. Prevention of drug abuse can be especially beneficial to the individual and society because of the high rates of relapse following treatment for drug abuse. For example, the rate of relapse following benzodiazepine detoxification has been reported to be over 90 percent (Seivewright N and Dougal W. Drug Alcohol Depend. 1993; 32:15-23; Seivewright et al., Int J Drug Policy. 1993; 4:42-48).
Centralized databases for recording and monitoring prescription medications have been proposed, see, e.g., U.S. Pat. No. 6,687,676. Recordation in a database alone (without drug labeling) does not address the problems of abuse in which the abuser receives drug from a third party, unauthorized provider (e.g., a friend, a drug dealer), or an unscrupulous or unknowing provider (e.g., an unknowing doctor). Use of a database alone, would not allow a prescriber to discern whether the abuse is occurring due to medications supplied by a third party or unscrupulous/unknowing provider because medication from the two sources can not be differentiated. The methods of the present invention would allow identification of the source of the illicit medication because any unlabeled medication in the patient's tissue or body fluid is evidence of abuse.